Many of our readers likely have seen media reports that the Food and Drug Administration (FDA) is strengthening its label warning about the relationship between use of certain pain medications and heart attacks and strokes. The drugs are all in a drug class known as non-steroidal anti-inflammatory drugs, or NSAIDs. Common over-the-counter NSAIDs that will have the new warnings include ibuprofen (Motrin, Advil) and naproxen (Aleve). (Although aspirin is an NSAID, the new warnings do not apply to aspirin.)
Here's what the FDA itself has to say:
Based on our review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:
- The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
- The risk appears greater at higher doses.
- It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
- NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
- In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
- Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
- There is an increased risk of heart failure with NSAID use.
For much more information from the FDA, begin here.